BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 2994100 · Received March 8, 2013

    Report

    Report Number
    1826988-2013-00083
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS HAD THREE LOW BLOOD GLUCOSE EPISODES WITHIN A MONTH AND PARAMEDICS HAD BEEN CALLED. DURING THE MOST RECENT EPISODE THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 70MG/DL ON THE CONTOUR NEXT LINK METER AND WHEN THE PARAMEDIC RE-TESTED HER USING A DIFFERENT METER THE READING WAS 40MG/DL. FURTHER INFORMATION ABOUT THE EVENT WAS NOT PROVIDED. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. PRODUCT IS NOT EXPECTED TO BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100149 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7309 2HFEC01

    Patients

    Seq Age Sex Outcome Treatment
    1